About this trial
The objective of this clinical study is to evaluate the safety, tolerability, pharmacokinetic, and pharmacodynamic profiles of SV003 in healthy subjects.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Body Mass Index (BMI): 18.5 ≤ Chinese participants ≤ 30 kg/m², 18.5 ≤ Caucasian participants ≤ 32 kg/m²; additionally, male participants must have a body weight ≥ 50 kg, and female participants ≥ 45 kg;
Healthy status: No evidence of active or chronic diseases in participants;
Ability to participate in the study, willingness to provide written informed consent, and compliance with study requirements.
Disqualifiers
Subjects with a history of chronic diseases or currently presenting with clinically significant systemic diseases;
Subjects who have experienced a serious disease within 1 month prior to drug administration, or with any disease that may relapse immediately during or after the study;
Subjects with designated examination results reaching a specified value;
Subjects with abnormal laboratory test results deemed clinically significant by the investigator;
Trial design
Sequential
Treatments tested in this trial
SV003
DrugSV003:Single-dose
Placebo
DrugPlacebo : Single-dose
Treatment groups
Trial outcomes
Primary outcomes
Incidence of Treatment-Emergent Adverse Events
Adverse event type, incidence, duration
Secondary outcomes
Peak Plasma Concentration (Cmax)
PK (Pharmacokinetics)
Peak time(Tmax)
PK (Pharmacokinetics)
Area under the plasma concentration versus time curve (AUC)
PK (Pharmacokinetics)
half-life(T1/2)
PK (Pharmacokinetics)
Sponsors and contacts
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